MAUDE Adverse Event Report: COOK INC FLEXOR RTPS GUIDING SHEATH; DYB INTRODUCER, CATHETER

Model Number	N/A
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/20/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Occupation: lead tech.Pma/510(k) #: preamendment.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.
Event or Problem Description
It was reported a flexor rtps guiding sheath was used in an unknown patient for an inferior vena cava filter removal.As reported, during the attempted removal of the sheath the "marker tip came off of the sheath and went inside the sheath.Everything was removed successfully at one time." as reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.D11: cook gunther tulip ivc filter 25mm goose-neck snare, unknown manufacturer.Investigation - evaluation.Reviews of the complaint history, device history record, instructions for use (ifu), manufacturer¿s instructions, and quality control procedures, and a visual inspection and dimensional verification of the returned device were conducted during the investigation.One used kcf-10.0-35-rb-rtps-100 sheath was returned without the inner dilator.The visual inspection of the returned device showed minimal biomatter.The distal tip was folded inward.On unfolding the tip, the overall sheath length measured 38.5cm.The distal end of the sheath lumen was occluded, and the distal tubing did not have coiling.The marker bend was not visible.The sheath was cut to find the source of occlusion.Tweezers were used to pull out extensive tnrt inner liner, the radiopaque marker band, and coiling.Additionally, a document-based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.A review of the device history record showed no nonconforming events which could contribute to this failure mode.It should be noted there were no other reported complaints for this lot number.Furthermore, reviews of the manufacturer¿s instructions and quality control procedures were conducted, and no gaps were discovered.The device is packaged with instructions for use (ifu), which state ¿flexor introducers and guiding sheaths are intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature." based on the information provided and the examination of the returned product, investigation has concluded that the device failure can be attributed to unintended use error, likely due to the gunther tulip filter legs catching on the distal tip of the sheath.We will continue our monitoring of similar complaints and have notified the appropriate personnel of this event.Per the quality engineering risk assessment, no further action is required.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
Additional Manufacturer Narrative
This mdr is being submitted as having information not previously reported.Additional complaint investigation and record remediation was not performed.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
Event or Problem Description
No new patient or event information since the last report was submitted.

• Brand Name: FLEXOR RTPS GUIDING SHEATH
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8726539
• Report Number: 1820334-2019-01502
• Device Sequence Number: 19284594
• Product Code: DYB
• UDI-Device Identifier: 00827002130814
• UDI-Public: (01)00827002130814(17)210619(10)8962620
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K142829
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/19/2021
• Device Model Number: N/A
• Device Catalogue Number: KCFW-10.0-35-RB-RTPS-100
• Device Lot Number: 8962620
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2019
• Initial Date Received by Manufacturer: 06/20/2019
• Supplement Date Received by Manufacturer: 09/13/2019; 03/20/2020
• Initial Report FDA Received Date: 06/24/2019
• Supplement Report FDA Received Date: 09/17/2019; 03/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1